Adjustable self-locking papillary muscle band

ABSTRACT

Embodiments of the present disclosure include a cardiac device comprising a band configured for deployment within a heart. The band may include a first end and a second end, an actuatable clasp associated with the first end of the band and configured to transition, upon actuation, from an open configuration to a closed configuration for forming the band into a fixed length loop after the second end is moved beyond the clasp. The clasp may be configured for actuation via a catheter. The cardiac device may include a clasp retainer associated with the clasp, the clasp retainer being configured to hold the clasp in the open configuration and the clasp being configured to be actuated upon movement of the clasp retainer, and a clasp actuator configured to move the clasp retainer thereby actuating the clasp.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. Non-Provisionalpatent application Ser. No. 16/166,291, filed Oct. 22, 2018, whichclaims priority from U.S. Provisional Patent Application No. 62/575,538,filed Oct. 23, 2017. The disclosures of the above-identifiedapplications are expressly incorporated herein by reference in theirentireties.

FIELD OF THE INVENTION

Some applications of the present invention relate in general to devicesand methods for improving cardiac function. More specifically, someapplications of the present invention relate to a cardiac device fortranscatheterly repositioning papillary muscles in a heart of a body.

BACKGROUND

Repositioning the papillary muscles within the ventricles of the heartduring atrioventricular valve repair surgery may improve outcomes. Thedisplacement of the papillary muscles, due to ischemia, heart failure,or other causes of ventricular reshaping, may result in tethering of thevalve leaflets, which may interfere with their normal functioning.Repairs that focus only on the valve annulus often result in recurrenceof regurgitation due to leaflet tethering.

Methods of papillary muscle repositioning include sutures from thepapillary muscle(s) up to the annulus of the valve or the aorta, slingsthat encircle multiple papillary muscles to pull the papillary musclestogether, and sutures to pull the papillary muscles together. However,these methods of papillary muscle repositioning are typically performedduring an open-heart surgery.

Another method of repositioning papillary muscles include positioning aband around the papillary muscles to improve cardiac function. Forexample, a transcatheter papillary muscle band is inserted into theventricle via a catheter and locked tightly around the base of thepapillary muscles to reposition the papillary muscles and improvecardiac function. Some transcatheter papillary muscle bands include aclasp, which can be actuated via a catheter to lock the band into a loopforming a sling. The clasp may lock onto any one of a number of ridgesor ledges along the band, thereby allowing adjustability of the size ofthe loop before locking the clasp.

In some sling designs, the distal end of the band containing the ridgesmay be pulled through the clasp until a desired loop size is achieved.Then, the clasp may be actuated to lock onto the ridge of the band thatlies within the clasp. Because the band is wrapped tightly around thepapillary muscles, during insertion, the distal end of the band may notbe inserted into the clasp in a straight configuration, but rather maybe inserted at an angle. Due to the angle at which the band is insertedinto the clasp, which may be often up to or greater than 90 degrees, thelocking ridges in the distal portion of the band may interfere withinsertion of the band into the clasp. For example, the ridges mayincrease the amount of force necessary to pull the band into the claspand may make the insertion jerky and difficult to control. Thisinterference with insertion into the clasp as a result of the ledges inthe band is referred to as the “ledge effect.” While a change in theradius of the band is the mechanical feature that allows the clasp tolock onto the ridges, the change in the radius is also the mechanicalfeature that interferes with smooth insertion of the band into theclasp.

Therefore, a need exists for systems and methods for performingpapillary muscle repositioning that is capable of reducing the ledgeeffect that interferes with smooth insertion of the band into the clasp.

SUMMARY

Presently disclosed embodiments recognize that a need exists forimproved devices and methods for repositioning papillary muscles, whichcan be more easily positioned, adjusted, and locked in place thanconventional devices and methods while also reducing the ledge effect.Additionally, presently disclosed embodiments may address the need fordevices and methods of repositioning papillary muscles that has thepotential to enable papillary muscle repositioning to be performed on apumping heart via a catheter. Moreover, conventional devices and methodsfor papillary muscle repositioning have had little commercial success.There is therefore a need for improved devices and methods, regardlessof whether delivered via a catheter or in some other way.

The embodiments of the present disclosure include devices and methods ofrepositioning papillary muscles. Advantageously, the exemplaryembodiments provide a method of repositioning papillary muscles bydelivering a band through a trabeculae. The band may comprise aplurality of sequential locking segments to be inserted into anadjustable clasp to form a loop. Various embodiments of the disclosuremay include one or more of the following aspects.

In accordance with an embodiment of the present disclosure, a cardiacdevice is provided, comprising a band configured to form a loop within aheart and including a first end and a second end, and a plurality ofsequential locking segments located in a region of the band near thesecond end. Each locking segment may include a ledged region and aramped region. The cardiac device may also comprise an adjustable clasplocated at or near the first end. The adjustable clasp may be configuredto form a fixed length loop by locking onto the ledged region of alocking segment after the second end has been inserted into the clasp.The adjacent locking segments may be configured to flex relative to eachother, thereby enabling adjacent ramped regions to cooperate with eachother to facilitate a sliding of the segments into the clasp.

According to an embodiment of the present disclosure, at least a portionof the band may be a tube, and the plurality of sequential lockingsegments may be located inside the tube. According to another embodimentof the present disclosure, each of the locking segments may becone-shaped. In some embodiments, the adjacent locking segments may belinked together by a mechanical joint configured to allow the lockingsegments to rotate relative to each other in at least one plane. In yetanother embodiment, the adjacent locking segments may include beadsstrung on a flexible wire. In some embodiments, the locking segments maybe separated by spacer beads. In some embodiments, at least a portion ofeach spacer bead may be located inside a hollowed interior of a lockingsegment.

According to another embodiment of the present disclosure, the adjacentlocking segments may include a hollowed interior such that the rampedregion of each locking segment can rotate relative to a centerline of achain of sequential locking segments to reduce a magnitude of a ledgebetween adjacent locking segments. In some embodiments, the plurality ofsequential locking segments may be integrally formed of a single piece,and the single piece may include regions connecting the plurality ofsequential locking segments. The regions may be more flexible than thelocking segments.

In yet another embodiment of the present disclosure, the ledged regionand the ramped region of the plurality of sequential locking segmentsmay be ramped and ridged in only one plane such that the ledged regionand the ramped region have at least one side that is smooth with noledges.

According to another embodiment of the present disclosure, the band maybe made of a material configured to allow the adjustable clasp to closeon an outside surface of the tube and lock firmly on the ledged regionof the locking segment inside the tube. In some embodiments, the bandmay include at least one of polytetrafluoroethylene (PTFE), expandedpolytetrafluoroethylene (ePTFE), or Dacron.

According to another embodiment of the present disclosure, the pluralityof sequential locking segments may include a first end and a second end.The second end of the band may be connected to the first end of theplurality of sequential locking segments. In some embodiments, thesecond end of the plurality of sequential locking segments may beconnected to a location along the band.

According to another embodiment of the present disclosure, the lockingsegments may include an indentation, and the indentation may beconfigured such that, when the band is flexed, adjacent locking segmentsare configured to align with each other such that there is no ledgebetween the adjacent locking segments, thereby providing a smoothsurface along an inner surface of the band.

In another embodiment of the present disclosure, the locking segmentsand the spacer beads may be configured such that, when the band isflexed, adjacent locking segments are configured to align with eachother such that there is no ledge between the adjacent locking segments,thereby providing a smooth surface along an inner surface of the band.

In yet another embodiment of the present disclosure, the regionsconnecting the plurality of sequential locking segments and the lockingsegments may be configured such that, when the band is flexed, adjacentlocking segments are configured to align with each other such that thereis no ledge between the adjacent locking segments, thereby providing asmooth surface along an inner surface of the band.

Additional objects and advantages of the embodiments will be set forthin part in the description that follows, and in part will be obviousfrom the description or may be learned by practice of the embodiments.The objects and advantages of the embodiments will be realized andattained by means of the elements and combinations particularly pointedout in the appended claims.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1A illustrates an exemplary device for repositioning papillarymuscles, in accordance with an embodiment of the present disclosure;

FIG. 1B illustrates an exemplary device for repositioning papillarymuscles, in accordance with another embodiment of the presentdisclosure;

FIG. 1C illustrates a zoomed-in view of the exemplary device of FIG. 1B.

FIG. 2 illustrates an exemplary band for repositioning papillary musclesin a loop, in accordance with another embodiment of the presentdisclosure;

FIG. 3 illustrates an exemplary anatomy of a human heart in whichembodiments of the present disclosure may be employed;

FIG. 4 illustrates an exemplary embodiment of an adjustable clasp, inaccordance with an embodiment of the present disclosure;

FIG. 5 illustrates another exemplary embodiment of an adjustable clasp,in accordance with an embodiment of the present disclosure;

FIG. 6 illustrates another exemplary embodiment of an adjustable clasp,in accordance with an embodiment of the present disclosure;

FIG. 7A illustrates an exemplary embodiment of an adjustable clasp, inaccordance with an embodiment of the present disclosure;

FIG. 7B illustrates another exemplary embodiment of an adjustable clasp,in accordance with an embodiment of the present disclosure;

FIG. 7C illustrates another exemplary embodiment of an adjustable clasp,in accordance with an embodiment of the present disclosure;

FIG. 7D illustrates another exemplary embodiment of an adjustable clasp,in accordance with an embodiment of the present disclosure;

FIG. 8 illustrates an exemplary body of a human in which embodiments ofthe present disclosure may be employed;

FIG. 9 illustrates an exemplary delivery device in which embodiments ofthe present disclosure may be employed;

FIG. 10 illustrates an exemplary delivery device with an exemplaryinsertion cable, in accordance with the embodiments of the presentdisclosure;

FIG. 11 illustrates another exemplary delivery device in whichembodiments of the present disclosure may be employed;

FIG. 12 illustrates an exemplary embodiment of a plurality of sequentiallocking segments, in accordance with the embodiments of the presentdisclosure;

FIG. 13A illustrates an exemplary embodiment of a cooperation ofadjacent locking segments when a sling is flexed, in accordance with theembodiments of the present disclosure;

FIG. 13B illustrates another exemplary embodiment of a cooperation ofadjacent locking segments when a sling is flexed, in accordance with theembodiments of the present disclosure;

FIG. 14 illustrates an exemplary embodiment of a plurality of lockingsegments with ball-in-socket joints, in accordance with the embodimentsof the present disclosure;

FIG. 15 illustrates exemplary embodiment of a plurality of lockingsegments with spacers strung on a wire, in accordance with theembodiments of the present disclosure;

FIG. 16A illustrates an exemplary embodiment of a hollow lockingsegment, in accordance with the embodiments of the present disclosure;

FIG. 16B illustrates an exemplary embodiment of a hollow locking segmentwith a ball-in-socket joint, in accordance with the embodiments of thepresent disclosure;

FIG. 16C illustrates an exemplary embodiment of a plurality of thehollow locking segments of FIG. 16A, in accordance with the embodimentsof the present disclosure;

FIG. 16D illustrates another exemplary embodiment of the plurality ofhollow locking segments of FIG. 16C when a sling is flexed, inaccordance with the embodiments of the present disclosure;

FIG. 17 illustrates another exemplary embodiment of a plurality ofsequential locking segments, in accordance with the embodiments of thepresent disclosure;

FIG. 18 illustrates an exemplary embodiment of a sling formed of a tubewith a plurality of sequential locking segments disposed inside thetube, in accordance with the embodiments of the present disclosure;

FIG. 19A is a graph illustrating a radius and slope along a length of aflexed chain of ball-shaped sequential locking segments, in accordancewith the embodiments of the present disclosure;

FIG. 19B is a graph illustrating a radius and slope along a length of aflexed chain of cone-shaped sequential locking segments, in accordancewith the embodiments of the present disclosure;

FIG. 19C is a graph illustrating a radius and slope along a length of aflexed chain of hollow cone-shaped sequential locking segments, inaccordance with the embodiments of the present disclosure;

FIG. 20A illustrates an exemplary embodiment of hollow cone-shapedlocking segments with an indentation, in accordance with the embodimentsof the present disclosure;

FIG. 20B another view of the hollow cone-shaped locking segments of FIG.20A, in accordance with the embodiments of the present disclosure;

FIG. 21 illustrates an exemplary embodiment of hollow cone-shapedlocking segments with spacers, in accordance with the embodiments of thepresent disclosure;

FIG. 22A illustrates an exemplary embodiment of radiopaque markers on adistal end of a delivery device, a clasp retainer, and a second end of asling, in accordance with the embodiments of the present disclosure;

FIG. 22B illustrates another exemplary embodiment of the radiopaquemarkers of FIG. 22A, in accordance with the embodiments of the presentdisclosure;

FIG. 22C illustrates another exemplary embodiment of the radiopaquemarkers of FIG. 22A, in accordance with the embodiments of the presentdisclosure;

FIG. 22D illustrates another exemplary embodiment of the radiopaquemarkers of FIG. 22A, in accordance with the embodiments of the presentdisclosure;

FIG. 23A illustrates an exemplary embodiment of radiopaque markers on adistal end of a delivery device, a clasp retainer, and a sling insertioncable, in accordance with the embodiments of the present disclosure;

FIG. 23B illustrates another exemplary embodiment of the radiopaquemarkers of FIG. 23A, in accordance with the embodiments of the presentdisclosure;

FIG. 23C illustrates another exemplary embodiment of the radiopaquemarkers of FIG. 23A, in accordance with the embodiments of the presentdisclosure; and

FIG. 23D illustrates another exemplary embodiment of the radiopaquemarkers of FIG. 23A, in accordance with the embodiments of the presentdisclosure.

DETAILED DESCRIPTION OF EMBODIMENTS

The present disclosure relates to methods and devices for improvingcardiac function. While the present disclosure provides examples ofrepositioning papillary muscles by looping a band around the pluralityof papillary muscles, it should be noted that aspects of the disclosurein their broadest sense, are not limited to looping a band around theplurality of papillary muscles. Rather, it is contemplated that theforgoing principles may be applied to other devices for improvingcardiac function as well. In addition, the looping may also occurthrough the plurality of spaces among the trabeculae to thereby pull theplurality of papillary muscles closer to each other and reposition thepapillary muscles. The plurality of spaces among the trabeculae may belocated along the walls of the ventricle of the heart. Accordingly,looping the band through the plurality of spaces among the trabeculaeand tightening the band in a single loop may pull the walls of theventricle of the heart inwards, thereby repositioning the papillarymuscles and pulling the papillary muscles closer to each other.

The term band refers generally to any element that is capable of eitherpartially or completely encircling a desired anatomy. For example, aband may be an element that is capable of partially or completelyencircling a plurality of papillary muscles in the ventricle of theheart in order to bring the papillary muscles closer to each other. Aband that loops around the plurality of papillary muscles, asillustrated in FIG. 3 , is one example of a device for repositioningpapillary muscles, in accordance with the present disclosure. Loopingmay involve partially or completely surrounding one or more papillarymuscles. As discussed above, looping may additionally or alternativelyinvolve passing the band through the plurality of spaces among thetrabeculae. In addition, the terms “ridges” and “ledges” refer generallyto any projection from a surface of a band, onto which a clasp can lockto form a loop. Accordingly, the terms “ridges” and “ledges” may be usedinterchangeably.

Referring to FIGS. 1A-1C, an exemplary device 100 for repositioningpapillary muscles, in accordance with the present disclosure, mayinclude a band 110. The band 110 may comprise a first end 120 and asecond end 130. The band 110 may be placed around at least one,optionally at least two, papillary muscles within a ventricle of aheart. The band 110 may be selectively configurable between an elongatedconfiguration, in which the first end 120 is disconnected from thesecond end 130, and a looped configuration, in which the band 110 isformed into a loop, as illustrated in FIGS. 1A-1C. In some embodiments,the band may be sized to simultaneously encircle a plurality ofpapillary muscles, thereby forming a loop around the papillary muscles,and pulling the papillary muscles toward each other. The term “band” mayinclude a tube. Alternatively, the band 110 may be a tube. In someembodiments, a portion of the band 110 may be a tube and another portionof the band 110 may not be a tube. The band 110 may have differentwidths along different portions of its length as illustrated in FIGS.1A-1C.

In some embodiments of the present disclosure, the band 110 may be madeof polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene(ePTFE), Dacron, and/or any other biologically inert synthetic materialwith appropriate tensile strength for use in pulling the papillarymuscles closer together. In other embodiments, the band 110 may bemanufactured by extrusion, knitting, weaving, braiding, or any othermethod of forming a biologically inert synthetic material into a band ora tubular band. The band 110 may be elastic, non-elastic, partiallyelastic, or any combination thereof. For example, a portion of the band110 may be elastic while another portion of the band 110 may benon-elastic. In some embodiments, the band 110 may be made of more thanone material. For example, a portion of the band 110 may be made of onematerial while another portion of the band 110 may be made of adifferent material. Alternatively, the band 110 may be made of abiological material from the patient, from another human donor, or fromanimal-derived material.

At or proximate the first end 120 of the band 110, at least onefastener, such as a clasp 150, may be provided. Clasp 150, for example,may be formed of a cut nitinol tube in the form of a crown. Additionallyor alternatively, clasp 150 may be formed in the form of a cylinder withmultiple flaps protruding from one end. Clasp 150 may be configured totransition from an open configuration (an example of which isillustrated in FIG. 1A) to a closed configuration (an example of whichis illustrated in FIGS. 1B and 1C), and vice versa. In the closedconfiguration, as illustrated in FIG. 1B, the flaps of the clasp 150 maybe bent inwards towards the center of the cylinder to form a clasp thatgrasps a portion of the band 110 that passes through the clasp 150. Theflaps may be sharp at the tip to firmly hold and/or puncture thematerial of the band 110 in the closed configuration. Alternatively, theflaps may be flat or rounded at the tip in order to close between one ormore protrusions on the band 110 and prevent a protrusion from passingthrough the clasp 150. In the open configuration, as illustrated in FIG.1A, the flaps may be straight with the wall of the cylinder and allowthe band 110 to pass through the clasp 150. The flaps may be biasedtowards the closed configuration and may be elastically bent into theopen configuration during positioning and adjustment of the band 110.The flaps may be allowed to return to the closed configuration uponactuation by a clasp actuator (not shown).

As illustrated by way of example in FIGS. 1A-1C, clasp 150 may beattached to the first end 120 of the band 110. In some embodiments, band110 may be a tube. Accordingly, clasp 150 may be located inside thefirst end 120 of the band 110. Clasp 150 may comprise one or more cutsin the wall of the tube. A wire or ring may be wrapped around theoutside of the band 110 over the one or more cuts in the tube, therebypushing the material of the band 110 into the cuts in the tube. Theforegoing feature may permanently or semi-permanently connect the band110 to the clasp 150.

The second end 130 of the band 110 may further comprise protrudingelements 140 (also called “graspable elements”) between which the clasp150 may close. The protruding elements 140 may be objects, soft or hardballs made of plastic, metal, and/or polymer, protrusions, spikes, orany material that is capable of being grasped by a clasp. In someembodiments, as illustrated in FIGS. 1B and 1C, the protruding elements140 cannot pass backwards through the closed clasp 150. In someembodiments, the protruding elements 140 may comprise hard balls locatedinside the band 110, the band 110 being a tube. The band 110 may bepinched between the hard balls by a ring, wire, or string around theoutside of the band 110, such that the hard balls cannot move within theband 110. Any number of protrusions can be made at the second end 130 ofthe band 110, and the clasp 150 may lock closed between any of theprotruding elements 140 or past the last protruding element 140, therebylocking at any one of a number of locations along the band 110.

In some embodiments of the present disclosure, the clasp 150 may connectto a distal end 160 of a delivery device 190 such that when the clasp150 is actuated, the clasp 150 is automatically disconnected from thedelivery device 190. An inner and outer diameter of the distal end 160of the delivery device 190 may be similar to the inner and outerdiameter of the clasp 150. In addition, the distal end 160 of thedelivery device 190 may be cut with a cut pattern that is complementaryto the shape of the flaps of the clasp 150 such that when the clasp 150is in the open configuration with the flaps bent into the cylindricalshape of the tube, the flaps of the clasp 150 may lock into the cutpattern of the distal end 160 of the delivery device 190, as illustratedin FIG. 1A. When the clasp 150 is allowed to return to the closedconfiguration, the flaps may bend inwards, thereby disconnecting fromthe cut pattern at the distal end 160 of the delivery device 190.Accordingly, the clasp 150 and the band 110 may disconnect from thedelivery device 190, as illustrated in FIG. 1B.

As illustrated by way of example in FIGS. 1A and 1B, device 100 mayfurther comprise a clasp actuator 180 and/or a pull wire 170. The pullwire 170 may be coupled to the clasp retainer ring 165 which is locatedwithin the clasp 150 and within the distal end 160 of the deliverydevice 190 such that upon actuation of the clasp by the clasp actuator180, the clasp retainer ring 165 may retract from the clasp 150.Accordingly, upon actuation by the clasp actuator 180, the clasp 150 maytransition into the closed configuration, in which the clasp 150 closesbetween the protruding elements 140 at the second end 130 of the band110. As such, the clasp 150 and the band 110 may disconnect from thedelivery device 190, thereby forming a loop.

According to another embodiment of the present disclosure, the band 110may be configured to be passed through the spaces among the trabeculaebetween the papillary muscles and the wall of the ventricle. FIG. 3 ,for example, illustrates a device 300 comprising a band 310 having aclasp 320. The band 310 may be configured to be passed through thespaces among the trabeculae 330 between the papillary muscles 340 andthe wall of the ventricle 350. In some embodiments of the presentdisclosure, two locations along the band may be attached together afterthe band has been passed around one, two, or more, papillary muscles inorder to form a loop. In some embodiments, the attachment is configuredsuch that the band or loop pulls the papillary muscles towards eachother.

In some embodiments of the present disclosure, the band may beconfigured such that it does not contact the opposing faces of thepapillary muscles. For example, the band may only contact the sides ofthe non-opposing surfaces of the papillary muscles. FIG. 3 , forexample, illustrates band 310 contacting only the sides of thenon-opposing surfaces of the papillary muscles 340. Alternatively, theband may be configured to contact the non-opposing sides of thepapillary muscles and to pull the papillary muscles towards each other.

In another embodiment of the present disclosure, the band may beconfigured to contact the papillary muscles such that opposing faces ofthe papillary muscles have no band material interposed between them. InFIG. 3 , for example, the band 310 loops around the papillary muscles340 such that there is no band material interposed between the papillarymuscles 340. Accordingly, the band 310 may be configured such that whenpositioned around the papillary muscles 340, there is no portion of theband 310 intervening between the papillary muscles 340 around which theband 310 is positioned. In some embodiments, the band 310 may beconfigured such that when it pulls the papillary muscles 340 together,the papillary muscles 340 can contact each other with no portion of theband 310 or other foreign material between them.

In some embodiments of the present disclosure, the two locations of theattachment which forms the band into a loop may be at the first end andthe second end of the band. The term “attachment” may refer to a claspor any material used to hold the ends of the band together to form aloop. Referring back to FIG. 1A, for example, the two locations of theattachment which forms the band 110 may be at the first end 120 and thesecond end 130 of the band 110. In some embodiments of the presentdisclosure, the two locations of the attachment which forms the band 110into a loop may be proximate the first end 120 and the second end 130 ofthe band 110. Alternatively, the attachment which forms the band 110into a loop may be closer to the first end 120 than to the second end130. In other embodiments, the attachment which forms the band 110 intoa loop may be in a fixed position relative to the first end 120 of theband 110, and its position relative to the second end 130 of the band110 can be varied in order to adjust the size of the band 110.

FIG. 2 , for example, illustrates a device 200 comprising a band 210.The band 210 comprises a first end 230, a second end 220, and a clasp240. The clasp 240 may be located in a fixed position relative to thefirst end 230 of the band 210. The position of the clasp 240 relative tothe second end 220 of the band 210 can be varied in order to adjust thesize of the loop formed by the band 210. Optionally, the attachmentwhich forms the band may attach one end of the band to any locationalong the band. In yet another embodiment, the attachment which formsthe band may attach any two locations along the band together.

In accordance with the embodiments of the present disclosure, the bandmay further comprise a clasp. FIGS. 1A-1C, for example, illustrate aband 110 comprising a clasp 150 that forms the attachment between thefirst end 120 and the second end 130 along the band 110 in order to forma loop. In some embodiments, the clasp 150 may be provided with the band110 and attached to the band 110. In other embodiments, the clasp 150may be attached to or near the first end 120 of the band 110. In otherembodiments, the clasp 150 may not be attached to the band 110 until theclasp 150 is actuated. When the clasp 150 is actuated, the clasp 150 mayattach to the first end 120 and the second end 130 of the band 110 toform a loop (an example of which is shown in FIG. 2 ). In someembodiments of the present disclosure, device 100 may further comprise aclasp actuator (not shown) that may be used to actuate the clasp 150.The position of the clasp 150 relative to the second end 130 of the bandmay be varied in order to adjust the size of the loop formed by the band110 until the clasp actuator (not shown) actuates the clasp 150. Forexample, once actuated, the clasp 150 may transition from an openconfiguration (an example of which is shown in FIG. 1A) to a closedconfiguration (an example of which is shown in FIGS. 1B and 1C).Alternatively, the length of the loop formed by the band 110 may beadjusted over a range of at least 5 mm, at least 8 mm, or at least 10mm.

In some embodiments, the clasp may be attached to a wall of the bandnear one of the ends of the band. FIG. 2 , for example, illustratesclasp 240 attached to a wall of the band 210 near the first end 230. Theclasp 240 may be attached to band 210 at the first end 230, for example,before implantation into the heart. The second end of the band may passthrough or past the clasp 240. For example, referring to FIG. 2 , thesecond end 220 of the band 210 may pass through or past the clasp 240.Upon actuation of the clasp 240 after implantation into the heart, theactuation may cause the clasp 240 to grasp a portion of the band 210that has passed through or past the clasp 240, thereby locking thesecond end 220 of the band 210 in a fixed position relative to the firstend 230 of the band 210. Accordingly, a loop may be formed.

The width or diameter of the band may be between about 2 mm and about 5mm. For example, the width or diameter of the band may be between about3 mm and about 4 mm. The width of the band may be constant along thelength of the band. Alternatively, the width of the band may vary alongits length and may be larger at one end than at the other end. Forexample, the end of the band to which the clasp is connected may have alarger width than the end of the band that is inserted into the clasp.Accordingly, the end of the band inserted into the clasp may have asmaller width.

In some embodiments, the band may comprise a tube. In some embodiments,the clasp may be located inside a first end of the band and/or may beattached to the wall of the band near the first end. FIG. 2 , forexample, illustrates the clasp 240 attached to a wall of the band 210near the first end 230. The second end of the band may pass through orpast the clasp within the inner lumen of the band. For example, thesecond end 220 of the band 210 may pass through or past the clasp 240within the inner lumen of the band 110. Upon actuation of the clasp 240after implantation into the heart, the actuation may cause the clasp 240to grasp a portion of the band 210 that has passed through or past theclasp 240, thereby locking the second end 220 of the band 210 in a fixedposition relative to the first end 230 of the band 210. Accordingly, aloop may be formed. In some embodiments, the clasp may be positionedwithin the band such that the band prevents the clasp from contactingthe heart tissue. FIG. 3 , for example, illustrates device 300comprising a band 310 and a clasp 320 located within the band 310. Theband 310 may prevent the clasp 320 from contacting the surroundingtissue in the ventricle 350 of the heart.

According to the exemplary embodiments of the present disclosure, theclasp may be configured to fix a length of the loop to correspond to theunique anatomy of the patient. In addition, the clasp may be configuredto be actuated within the heart of the patient. Accordingly, the claspmay be configured to be selectively actuatable to fix a length of theloop formed by the band such that the loop corresponds to the uniqueanatomy of the patient. As discussed above, the clasp may have multiplemechanical configurations. For example, during insertion and positioningof the band within the heart of the patient, the clasp may be in an openconfiguration (an example of which is shown in FIG. 1A). In the openconfiguration, for example, an insertion cable (not shown) and a secondend of the band may move freely through or past the clasp. Once the bandis properly positioned and adjusted, a clasp actuator may be used toactuate the clasp, reconfiguring it to a closed configuration (anexample of which is shown in FIGS. 1B and 1C). In the closedconfiguration, for example, the clasp may grasp a portion of the bandthat has passed through or past the clasp, thereby preventing the bandfrom moving relative to the clasp and forming a loop.

The clasp may be a clip, grasper, catch, fastener, buckle, or any othertype of clasp that is capable of attaching one location of the band toanother location of the band. FIG. 4 illustrates various exemplaryembodiments of the clasp in open and closed configurations. For example,as seen in FIG. 4 , the clasp may be a bear trap type clasp 410, a cliptype clasp 420, a fastener type clasp 430, a self-locking zip tie typeclasp 440, a buckle type clasp 450, a fastener type clasp 460, or anyother type of clasp capable of attaching one location of the band toanother location of the band.

In some embodiments, the clasp may be made of a metal, for example,spring steel, stainless steel, and/or nitinol. In other embodiments, theclasp may be made of a polymer material, or any other material with themechanical properties necessary to provide an open configuration and aclosed configuration. In some embodiments, the clasp may be biasedtowards a closed configuration and may be elastically deformed into anopen configuration until being actuated by the clasp actuator. Forexample, the clasp actuator may allow the clasp to return to the closedconfiguration. A second end of the band may be passed through or pastthe clasp in the open configuration. Accordingly, when the second end ofthe band is properly positioned, the clasp actuator may allow the claspto elastically return to the closed configuration such that the claspmay grasp the band and lock the band in place, thereby forming a loop.

In other embodiments, the clasp may be biased toward an openconfiguration and may be deformed into a closed configuration whenactuated by the clasp actuator. For example, the clasp actuator mayforce the clasp into the closed configuration. In such embodiments, thesecond end of the band may pass through or past the clasp in the openconfiguration. When the second end of the band is properly positioned,the clasp actuator may force the clasp into the closed configurationsuch that the clasp may grasp the band and lock the band in place,thereby forming a loop.

According to another embodiment of the present disclosure, the clasp maybe a cylinder with elastic elements that extend inward into the insideof the cylinder. In the open configuration, the elastic elements of theclasp may be held outwards in or near the wall of the cylinder. FIG. 5 ,for example, illustrates various embodiments of the clasp that may be acylinder. For example, a clasp 510 may be manufactured from a cut tubein which the elastic elements are cut from the wall of the tube and thenbent inwards. The clasp 510 may be configured to grasp a portion of theband at any location along the band or the clasp 510 may be configuredto grasp a graspable component or feature located at a certain locationalong the band. The clasp 510 may be held in the open configuration by atube (not shown) placed within the clasp 510. The clasp 510 may beactuated to return to its closed configuration by removing the tube fromwithin the clasp 510.

Alternatively, a clasp 520 may be made from bent wire, such as a coilspring, and the elastic elements may be portions of the bent wire thatare configured to extend inwards into the inside of the cylinder. Theclasps 510 and 520 may be flexible so that the band in the region of theclasps 510 and 520 remains flexible. This flexibility may be achieved bythe design of the bent wire spring or by cuts in the wall of the cuttube configured to add flexibility to the tube.

In another embodiment, the clasp may be a disc with a plurality of cutsthat form a plurality of leaves. The plurality of leaves may rotate outof the plane of the disc. FIG. 6 , for example, illustrates clasp 610with a plurality of cuts 620 that form a plurality of leaves 630. Theperimeter of the clasp 610 may remain intact and the leaves 620 may beconnected to the clasp 610 near the perimeter such that when the leaves620 rotate out of the plane of the clasp 610, the leaves 620 may leavean open channel 640 through the middle of the clasp 610. The leaves 620may be configured such that when an object (not shown) is passed in onedirection through the open channel 640 through the middle of the clasp610, the leaves 620 may press against the object and prevent or reducethe likelihood of the object passing back in the opposing directionthrough the open channel 610. In another embodiment, the leaves 620 maycomprise at least one spike 650 at the region that contacts the object(not shown) that is passing through the open channel 640. Accordingly,if the object passing through is capable of being penetrated, spike 650may penetrate the object and increase the ability of the clasp 610 tograsp the object passing through the clasp 610.

While only one clasp 610 is illustrated in FIG. 6 , multiple clasps 610may be used together in order to increase the strength with which theclasps 610 may grasp an object passing through them. Alternatively, asingle clasp 610 may comprise multiple layers of leaves 630, therebyincreasing the strength with which the clasp 610 may grasp an objectpassing through it. Such a multi-layered clasp may be made flexible suchthat a portion of a band, to which the clasp is connected, may remainflexible. Clasp 610 may be manufactured by cutting or stamping the formof the clasp 610 out of a flat sheet or by cutting the form of the clasp610 out of a tube and bending the leaves 630 inward.

In some embodiments, the clasp may be made of a plurality of panels.FIGS. 7A-7B, for example, illustrate clasp 710 comprising a plurality ofpanels 720. The panels 720 may comprise a plurality of spikes 730protruding from the panels 720. The spikes 730 may press against eachother to grasp a band, for example, passing between the panels 720. Thepanels 720 may be connected at their edges by elastic components thatinduce the panels 720 to press against each other. The panels 720 may beflexible such that they naturally press flat against each other, but canbe elastically deformed into a curved shape, as illustrated by way ofexample in FIGS. 7A-7B.

The clasp 710 may be cut from a tube with the panels 720, and theelastic components that hold the panels 720 together at their edges mayalso be cut from the same tube. The spikes 730 protruding from thepanels 720 may be cut from the wall of the panels 720 and bent inwardsto form the protruding spikes 730. The spikes 730 and/or the panels 720may be elastically deformed outward into an open configuration of theclasp 710 by placing an inner tube (not shown) between the panels 720.Upon removal of the inner tube, the spikes 730 and the panels 720 mayreturn to a closed configuration, in which the spikes 730 may protrudeperpendicularly to the panels 720, and the panels 720 may press againsteach other.

In other embodiments, the clasp may be composed of a ring with spikesprotruding from the ring. FIG. 7C-7D, for example, illustrate clasp 740comprising a ring 750 with a plurality of spikes 760 protruding from thering 750. In a closed configuration (examples of which are shown in FIG.7C-7D), the spikes 760 may lay across part (FIG. 7C) or all (FIG. 7D) ofthe inside of the ring 750. In an open configuration, the spikes 760 maybe rotated out of the plane of the ring 750 and may allow an object,such as a band, to pass through the center of the ring 750. The spikes760 may be biased towards the closed configuration and may beelastically rotated into the open configuration during positioning andadjustment of a band around the papillary muscles. Then, the spikes 760may be allowed to return to the closed configuration upon actuation by aclasp actuator. Alternatively, the spikes 760 may be biased toward theopen configuration and may be forcibly bent into the closedconfiguration upon actuation by the clasp actuator. In some embodiments,the spikes 760 may be configured to rest against the ring 750 orprotrusions (not shown) extending from the ring 750 in the closedconfiguration such that the spikes 760 may not rotate past the plane ofthe ring 750.

As discussed above, the clasp may be locked into a closed configurationupon actuation by a clasp actuator. In some embodiments of the presentdisclosure, the clasp actuator may be configured to enable actuation ofthe clasp remotely, such as from outside of the heart. In otherembodiments, the clasp actuator may be configured to enable actuation ofthe clasp from outside of the body of the patient. Accordingly, theclasp actuator may be configured to enable the user to actuate the claspfrom a location distant from the clasp.

FIG. 8 , for example, illustrates a clasp actuator 800 that may enablethe user to actuate the clasp 840 from outside of the body 830. Theclasp actuator 800 may include pull wires, rotating shafts, rotatingtubes, moveable shafts, moveable tubes, electrical actuators, pneumaticactuators, hydraulic actuators, or any other means of providingactuation remotely in order to actuate a clasp located within the heartfrom outside of the body. For example, clasp actuator 800 may beconfigured to allow the actuation of clasp 840 via a flexible catheter820 from outside of the body 830. In some embodiments, the claspactuator 800 may further include a trigger 810 located outside of thebody 830 that can be used to actuate the clasp 840 located inside theheart.

In some embodiments of the present disclosure, the first end of the bandmay be mounted on a delivery device in order to encircle the band aroundthe papillary muscles. The delivery device may incorporate part of orall of the clasp actuator within the device. Further, the deliverydevice may include a rigid or flexible tube. Alternatively, the deliverydevice may comprise a tube having rigid portion(s) and flexibleportion(s). The delivery device may include a tube or a conduit thatpasses through a side wall of the band configured to form a loop aroundthe papillary muscles.

By way of example, FIG. 9 illustrates an exemplary delivery device 910connected near the first end 980 of the band 970. The band 970 maycomprise an opening 930 on a side wall of the band 970, through whichthe removable delivery device 910 may pass. The delivery device 910 maypass through the wall of the band 970 near the first end 980 such that aportion of the delivery device 910 is within a portion of the band 970near the first end 980. The portion of the band 970 that comprises thedelivery device 910 within the band 970, e.g., distance from the firstend 980 of the band 970 to the location where the delivery device 910passes through the opening 930 of the band 970, may be in the range ofabout 5 mm to about 25 mm. For example, the distance may be in the rangefrom about 10 mm to about 15 mm. In some embodiments, clasp 940 may belocated within 25 mm, 15 mm, 10 mm, or 5 mm from the first end 980 ofthe band 970. The clasp 940 may be located within the portion of theband 970 that has the delivery device 910 within it. In someembodiments, the components of the clasp actuation mechanism, forexample pull wires or a clasp retainer ring, that engage the clasp maybe located in the portion of the delivery device 910 that is within theband 970. The clasp 940 may be located at one end of the delivery device910. The other end of the delivery device 910 may be located outside ofthe patient's body. In other embodiments, the clasp actuation mechanismmay include an elongated member that may pass through the deliverydevice 910.

The delivery device 910 may further include a region proximal to thelocation where the delivery device 910 passes through an opening 930 ofthe band 970 that may be flexible and/or actively deflectable. Thedeflection of the deflectable region 920 may be controllable between atleast 0 degrees and 90 degrees. In some embodiments, the delivery device910 may further include an insertion cable threader 960 protruding fromboth ends of the delivery device 910. One end of the threader 960protruding from one end of the delivery device 910 may comprise agrasper 950 configured to grasp an insertion cable (not shown) coupledto the band 970. In some embodiments, the grasper 950 may removablygrasp the insertion cable coupled to the band 970. The other end of thethreader 960, which protrudes from the other end of the delivery device910, may be configured to be pulled to pull the insertion cable (notshown) through the delivery device 910. The insertion cable may bereleased from the threader 960 after having been pulled through thedelivery device 910.

In some embodiments, an insertion cable coupled to a band may beprovided in order to aid in the insertion of the band into the heart. Byway of example, FIG. 10 illustrates a device 1000 comprising aninsertion cable 1050 coupled to a band 1010. The insertion cable 1050may aid in the insertion of the band 1010 into the heart and around thepapillary muscles. In some embodiments, the insertion cable 1050 may aidin the insertion of the band 1010 into a clasp 1040.

In accordance with the embodiments of the present disclosure, a distalend of the insertion cable 1050 may be removably connected to the secondend 1030 of the band 1010. The insertion cable 1050 may be configured toadjust the size of a loop formed by the band 1010 encircling thepapillary muscles. The insertion cable 1050 may be flexible, such thatthe insertion cable 1050 may aid in guiding the band 1010 around thepapillary muscles to form a loop. The proximal end of the insertioncable 1050 may be configured to be passed through the spaces among thetrabeculae between the papillary muscles and the wall of the ventricle.Further, the insertion cable 1050 may fit into the first end 1020 of theband 1010 and through or past the clasp 1040 when the clasp 1040 is inan open configuration. Alternatively, the insertion cable 1050 may fitinto a distal end of a delivery device (an example of which isillustrated in FIG. 9 ) which may be located within the first end 1020of the band 1010.

In an alternative embodiment, the insertion cable 1050 may furthercomprise an insertion cable release trigger (not shown) located at ornear the proximal end of the insertion cable 1050. The distal end of theinsertion cable 1050 may be configured to separate from the second end1030 of the band 1010 upon actuation of the insertion cable releasetrigger. In some embodiments, the insertion cable release trigger may bethe proximal end of a wire or tube (not shown) extending through thelumen of the insertion cable 1050 which is pulled, pushed, rotated, orotherwise manipulated, to actuate the release of the insertion cable1050.

The band 1010 may be releasably connected to the insertion cable 1050.For example, the insertion cable may be releasably connected to the band1010 by way of an insertion cable adapter 1060. The insertion cableadapter 1060 may be attached to the second end 1030 of the band 1010. Inother embodiments, the insertion cable adapter 1060 may be permanentlyattached to the second end 1030 of the band 1010, and the insertioncable 1050 may be removably attached to the insertion cable adapter1060.

In some embodiments, at least a portion of the band may be pre-loadedinto a tube. By way of example, FIG. 11 illustrates at least a portionof a band 1110 pre-loaded into a tube 1120. Alternatively, at least aportion of the band 1110, at least a portion of the insertion cable 1170attached thereto, and at least a portion of an attached delivery device1180 may be pre-loaded into a tube 1120.

Referring back to FIG. 10 , the band 1010, a delivery device (notshown), and the insertion cable 1050 may be configured for insertioninto the heart via a transthoracic approach, a transarterial approach, atransvenous approach, a transarterial/transaortic approach, atransveous/transseptal/transmitral approach, or any other surgical orminimally invasive approach to the heart.

In some embodiments, a clasp 1040 may be attached at or near the firstend 1020 of the band 1010 and may be configured to grasp the band 1010at a location where the band 1010 passes through or past the clasp 1040.Accordingly, the amount of band adjustment necessary to form a loop of adesired circumference may be independent of the length of the clasp1040.

As discussed above, the clasp 1040 may be attached at or proximate thefirst end 1020 of the band 1010 and may be configured to grasp agraspable component or feature located at or proximate the second end1030 of the band 1010, or at any location along the band 1010. In otherembodiments, multiple graspable components or features may be located atmultiple locations along the band 1010. The clasp 1040 may be configuredto grasp a graspable component or feature at multiple locations or atany location along the length of the clasp 1040. In some embodiments,the amount of band adjustment necessary to form a loop of a desiredcircumference may be dependent upon the length of the clasp 1040 and thenumber of locations of the graspable components or features since agraspable component or feature may need to be within the clasp to begrasped (an example of which is shown in FIGS. 1A-1C).

In some embodiments, the clasp 1040 may interact with the material ofthe band 1010 itself in achieving the grasping. In other embodiments,there may be a component or feature at a location in or on the band 1010that the clasp 1040 may grasp. The graspable component or feature thatthe clasp 1040 may grasp may be movable relative to the position of thesecond end 1030 of the band 1010.

Clasp 1040 may be attached to the wall of the band 1010 at or proximatethe first end 1020 of the band 1010 using glue or adhesive. Additionallyor alternatively, clasp 1040 may be attached using melting or thermalbonding to the wall of the band 1010, using suturing, stitching, orsewing to the wall of the band 1010, using clasp elements that couplethe clasp 1040 onto the wall of the band 1010, or any other attachmentmethod or combination of attachment methods that can attach the clasp1040 to the wall of the band 1010.

By way of example, FIG. 11 illustrates a band 1110 comprising aplurality of graspable components 1130 at or proximate the second end1150 of the band 1110. The graspable elements 1130 may be objects, softor hard balls made of plastic, metal, and/or polymer, protrusions,spikes, or any material that is capable of being grasped by a clasp. Ator proximate the first end 1160 of the band 1110, a clasp 1140 may beprovided that is configured to grasp at least one of the graspablecomponents 1130. The second end 1150 of the band 1110 may be pulledthrough the first end 1160 of the band 1110. Then, the clasp 1140 may beconfigured to transition from an open configuration to a closedconfiguration upon actuation by a clasp actuator to grasp at least oneof the graspable components 1130 in order to form a loop of a desiredcircumference, preferably based on the unique anatomy of the patient.

Referring back to FIG. 1A-1B, in some embodiments, the distal end of thedelivery device 190 may include a clasp retainer ring 165 within anouter tube of the delivery device 190. The distal end of the outer tubemay be located proximally to the clasp 150 and have a diameter such thatthe clasp 150 cannot fit into the outer tube. The clasp retainer ring165 may extend distally beyond the distal end of the outer tube and bepositioned within the clasp 150, holding the clasp 150 in an openconfiguration (an example of which is illustrated in FIG. 1A).Accordingly, the clasp 150 may be biased towards a closed configurationand may be held in the open configuration by the clasp retainer ring 165located within the clasp 160. The actuation of the clasp 150 may includepulling the clasp retainer ring 165 proximally relative to the outertube such that the clasp retainer ring 165 is retracted from within theclasp 150 into the outer tube, thereby allowing the clasp 150 to returnto a closed configuration (an example of which is illustrated in FIG.1B). Additionally or alternatively, pull wires or a pull-tube may beconnected to the clasp retainer ring 165, and may run through thedelivery device 190 to the proximal end of the delivery device 190. Atthe proximal end of the delivery device 190, the pull wires or pull-tubemay be connected to a trigger that may pull the pull wires proximallyrelative to the delivery device 190 in order to retract the claspretainer ring 165 into the outer tube. After actuation of the clasp 150,the delivery device 190 may be removed from the band 110.

In some aspects, the insertion cable (an example of which is shown inFIG. 10 ) may comprise a tube with a wire located within the tube. Thedistal end of the tube may have longitudinal slits splitting the wall ofthe tube into multiple flaps. The flaps may have thickened walls attheir distal tips such that when the wire is inside the tube, the distalend of the tube may be unable to fit through a hole whose diameter isthe same as the outer diameter of the tube. However, when the wire isremoved from the distal end of the tube, the distal end of the tube maybe able to fit through a hole whose diameter is the same as the outerdiameter of the tube. In other embodiments, the distal region of thewire that holds the flaps outward may have a larger diameter than therest of the wire. In some aspects, the tube may be a coil with a solidtubular region at the distal end. The coil may be tightly wound to avoidcompression and have a wire or ribbon running through the coil connectedat both ends to avoid stretching.

According to one embodiment of the present disclosure, the flaps may beformed by cutting through the wall of the tube near the distal end. Thethickening of the walls of the distal tips of the flaps may be formed bybending the distal tips of the flaps back on themselves one or moretimes. The distal portion of the tube of the insertion cable from whichthe flaps are formed may be made of metal, polymer, or plastic or anyother material capable of being formed into flaps with thickened walls.

In other aspects, the flaps may have a radially outward step before thethickened portion. Accordingly, the insertion cable may not be allowedto pass through a hole whose diameter is the same as the outer diameterof the tube without applying excessive force on the wire that is holdingthe flaps outwards. Additionally or alternatively, the flaps may bebiased radially inwards so that when the wire is not located within theregion of the tube containing the flaps, the flaps may bend inwards, andthe tube may pass freely through a hole whose diameter is the same asthe outer diameter of the tube.

Referring back to FIG. 10 , an insertion cable adapter 1060 may beattached to the second end 1030 of the band 1010. The insertion cableadapter, for example, may have a channel (not shown) through it with adiameter equal to or slightly greater than the outer diameter of thetube of the insertion cable 1050. A region of the channel may have adiameter large enough to fit the distal end of the tube with the wireinside of it. Diameters of the tube, the thickened flaps at the distalend of the tube, and the narrow and wide regions of the channel in theadapter may be configured such that, when the outer tube is inside thechannel in the adapter and the wire is inside the distal end of thetube, the tube may become locked in the adapter because its distal endcannot fit through the narrow region of the channel. As such, when thewire is removed from the distal end of the tube, then the tube may beremoved from the adapter. The wire may extend through the tube,additionally or alternatively extending beyond the proximal end of thetube, so that the wire can be pulled from the proximal end to retractthe wire out of the distal end of the tube in order to detach theinsertion cable from the adapter. Additionally or alternatively, theproximal end of the wire may be attached to a puller, which may beremovably attached to the proximal end of the tube. Accordingly, whenthe puller is removed and pulled away from the tube, the puller may pullthe wire along with it, thereby retracting the wire from the distal endof the tube. In some aspects, the puller may be removably attached tothe proximal end of the tube by being screwed onto or screwed into thedistal end of the tube. Alternatively, the puller may not be at thedistal end of the tube but may be located in the middle of the tube nearthe distal end.

In some aspects, the insertion cable may be removably connected to theinsertion cable adapter by one or more wires, fibers, or other thinelongated elements passing out through the holes in the wall of the tubeand passing back into the tube through holes in the insertion cableadapter and in the wall of the tube. The wires, fibers, or other thinelongated elements may extend through the tube and may be pulled at ornear the proximal end of the tube to remove them from the holes, therebyreleasing the connection of the insertion cable to the insertion cableadapter. The insertion cable may be a suture, string, fiber, or wirethat is cut in order to detach the insertion cable from the second endof the band. The insertion cable may be a flexible torque cable ortorque tube with a screw at its distal end. The screw at the distal endof the insertion cable may be screwed into the insertion cable adapterconnected to the second end of the band. Accordingly, turning theproximal end of the insertion cable may cause the distal end of theinsertion cable to unscrew from the insertion cable adapter and detachfrom the band. In other embodiments, the flexible torque cable or torquetube may be covered by a flexible braided tube to enhance its tensilestrength. The flexible braided tube may be made of metal, polymer, silk,or any other biocompatible material that can be made into a fine braidand used to cover the torque cable or torque tube adding tensilestrength.

According to another embodiment of the present disclosure, a cardiacimplant is provided. The cardiac implant may comprise a papillary bandformed of a tube with an opening in a side wall of the tube and aremovable conduit passing through the opening. The cardiac implant mayadditionally comprise a clasp associated with the band. The clasp may beconfigured to be actuated by an elongated member, which passes throughthe removable conduit. Upon actuation, the clasp may attach twolocations along the band to each other forming the band into a loop. Theclasp may be located at a distal end of the conduit, and the proximalend of the conduit may be located outside of the patient's body. Theremovable conduit may be configured to be removed from the tube afteractuation of the clasp.

As discussed above, the band may be configured to contact non-opposedsurfaces of the papillary muscles. The band may be configured toencircle a plurality or a cluster of papillary muscles, thereby pullingthe papillary muscles toward each other with no portion of the bandbeing interposed between the papillary muscles (an example of which isshown in FIG. 3 ).

According to another embodiment of the present disclosure, a cardiacimplant is provided. The cardiac implant may comprise a papillary bandhaving a first end and a second end and being selectively configurablebetween an elongated configuration where the first end is disconnectedfrom the second end, and a looped configuration where the band is formedinto a loop. The cardiac implant may further comprise a clasp attachedto the band, closer to the first end of the band than to the second endof the band. The implant may further comprise an elongated insertioncable removably connected to the second end of the band. The papillaryband may be configured to form a loop simultaneously encircling a groupof papillary muscles, and the elongated insertion cable may beconfigured to adjust the size of the loop. The band may be configured tocontact non-opposed portions of the papillary muscles. The band may beconfigured to encircle a plurality of papillary muscles, thereby pullingthe plurality of papillary muscles toward each other with no portion ofthe band being interposed between the papillary muscles. In someembodiments, the clasp may be selectively configurable between twoconfigurations—an open configuration and a closed configuration. In theopen configuration, the insertion cable and the second end of the bandmay pass through the clasp. In the closed configuration, the region ofthe band which passes through the clasp may be held in place so that theband cannot move with respect to the clasp.

According to another embodiment of the present disclosure, a band maycomprise a sling including an actuatable clasp and a plurality ofsequential locking segments configured to slide into the actuatableclasp. For example, as shown in FIG. 12 , a band may comprise a sling1200 and a plurality of sequential locking segments 1210. Each lockingsegment 1210 may comprise a ledged region 1220 and a ramped region 1230.Adjacent locking segments 1210 may be configured to flex relative toeach other to thereby enable adjacent ramped regions 1230 to cooperatewith each other and facilitate a sliding of the locking segments 1210into an actuatable clasp, such as clasp 240 of FIG. 2 and/or clasp 1140of FIG. 11 .

As shown in FIG. 12 , in ramped region 1230, the radius of each lockingsegment 1210 may increase with increasing distance from one end 1240 ofsling 1200. Accordingly, in ramped region 1230, the outer surface oflocking segment 1210 may have a positive slope. In contrast, in ledgedregion 1220, the radius of each locking segment 1210 may decrease withincreasing distance from end 1240 of sling 1200. Accordingly, in ledgedregion 1220, the outer surface of locking segment 1210 may have anegative slope.

In some embodiments, a clasp, such as an actuatable clasp, may lock onthe decreased radius of ledged region 1220. As such, the larger positiveslope of ramped region 1230 may increase the force necessary to pullsling 1200 into the clasp. Accordingly, the design of locking segments1210 may need to minimize the positive slope of ramped region 1230 whilemaintaining sufficient ledge, onto which the clasp can lock.

In some embodiments of the present disclosure, a cooperation of adjacentlocking segments when a sling is flexed may reduce a magnitude of ledgesalong an inner side of the flexed sling, thereby reducing the ledgeeffect. For example, as shown in FIGS. 13A and 13B, when sling 1300 isflexed, adjacent locking segments 1310 cooperate with each other and,thus, magnitudes of ledges 1320 are reduced along an inner side 1330 ofthe flexed sling 1300. Accordingly, when sling 1300 is flexed andmagnitudes of ledges 1320 are reduced, sling 1300 may be able to slidethrough a clasp more easily.

According to some embodiments of the present disclosure, the lockingsegments may be cone-shaped. For example, as shown in FIG. 14 , lockingsegments 1410 may be cone-shaped and, thus, ledged regions 1420 andramped regions 1430 may be formed by the cone-shaped segments 1410.Additionally or alternatively, the plurality of locking segments 1410may comprise individual locking parts that are configured to fittogether in a way that allows locking segments 1410 to flex relative toeach other. For example, the plurality of locking segments 1410 may fittogether with a ball-in-socket joint 1440, a cylinder-in-socket joint,or any other similar type of joint that is capable of locking adjacentsegments together while allowing the segments to rotate relative to eachother in at least one plane.

In some embodiments, the plurality of locking segments may be strungonto a band, a sling, a wire, a thread, a string, a cable, or the like.Optionally, spacers may be located between each locking segment. Forexample, as shown in FIG. 15 , a sling 1500 contains a plurality oflocking segments 1510 strung onto a wire with spacers 1520 betweenlocking segments 1510. The plurality of sequential locking segments 1510may be individually coupled to the wire so that they cannot move alongthe wire. In some embodiments, spacers 1520 may be strung onto the wirebetween adjacent locking segments 1510. In some embodiments, spacers1520 may be strung between some adjacent locking segments 1510, but notbetween every adjacent locking segment 1510. In some embodiments, thespacers 1520 may be coupled to the wire and hold the locking segments1510 in place. Additionally or alternatively, only the first and last ofthe plurality of locking segments 1510 may be coupled to the wire ontowhich they are strung. Accordingly, the first and last of the pluralityof locking segments 1510 may be configured to hold the remaining lockingsegments 1510 in place. In yet another embodiment, the plurality ofsequential locking segments 1510 may not be coupled to the wire. Rather,other components may be coupled to the wire at the ends of the pluralityof locking segments 1510 and the components may be configured to keepthe locking segments 1510 in place.

According to some embodiments of the present disclosure, the pluralityof sequential locking segments may be integrally formed as a singlepiece. The single piece may comprise regions that are more flexible thanthe locking segments. The more flexible regions may connect the lessflexible locking segments. In some embodiments, the more flexibleregions connecting the locking segments may be made of a material thatis different from the material that is used to make the less flexiblelocking segments. Accordingly, different flexibilities of differentregions may result from the use of different materials with differentmechanical properties. Additionally or alternatively, the entire chainof sequential locking segments, including the flexible regions and thelocking segments, may be made of the same material. Accordingly,different flexibilities of different regions may result from differentthicknesses of the same material. For example, the more flexible regionsmay comprise a first thickness of a material, and the locking segmentsmay comprise a second thickness of the same material. The secondthickness may be greater than the first thickness. That is, the lockingsegments may be thicker than the flexible connecting regions.

In some embodiments, the ramped region of the locking segments maycomprise a hollowed interior. For example, as shown in FIGS. 16A and16B, locking segments 1600 may comprise a hollowed interior 1610, suchas an undercut. The hollowed interior 1610 may allow each lockingsegments 1600 to rotate relative to a centerline of a chain ofsequential locking segments 1600. Accordingly, the magnitude of theledge on an inner side of a flexed sling may be reduced. For example, asdiscussed with respect to FIGS. 13A and 13B, when a sling of a pluralityof locking segments is flexed, adjacent locking segments may cooperatewith each other and, thus, magnitudes of ledges may be reduced along aninner side of the flexed sling. Accordingly, the sling may be able toslide through a clasp more easily. Similarly, FIG. 16C illustrates asling 1620 of a plurality of sequential locking segments 1600 that isnot yet flexed. In contrast, FIG. 16D illustrates the sling 1620 that isflexed. As shown in FIGS. 16C and 16D, when sling 1620 of lockingsegments 1600 is flexed, magnitudes of ledges 1630 are significantlyreduced on an inner side of the flexed sling 1620. The hollowed interior1610 of each locking segment 1600 may allow adjacent locking segments1600 to cooperate with each other better when sling 1620 is flexed, andthus, facilitate further reduction of magnitudes of the ledges.

In some embodiments of the present disclosure, a ramped region of alocking segment may expand in radius in only one plane or in only onedirection. For example, as shown in FIG. 17 , a ramped region 1700 of alocking segment 1710 may expand in radius in only one plane. When rampedregion 1700 expands in radius in only one plane, the ledge effect may besubstantially eliminated entirely, with the exception of some possiblevariation in force due to non-uniform bending. In addition, when rampedregion 1700 expands in radius in only one plane, the locking strength ofa clasp may be reduced because the ledges 1720 of each locking segment1710 expand in only one plane as well within a thickness of each lockingsegment 1710.

In some embodiments of the present disclosure, the band may comprise atube and a plurality of sequential locking segments may be disposedinside the tube. For example, as seen in FIG. 18 , a plurality ofsequential locking segments may be disposed inside tube 1800. Tube 1800may be made of a soft, flexible material such that a clasp can close onan outside surface of tube 1800 and lock firmly onto a ledged region ofa locking segment disposed inside tube 1800. In some embodiments, tube1800 may be made of ePTFE, Dacron, or any other biocompatible materialthat is soft and flexible. In some embodiments, one end of tube 1800 maybe connected to one end of a chain of sequential locking segments. Inother embodiments, one end of tube 1800 may be connected to one end ofthe chain of sequential locking segments through an adapter. Forexample, an adapter may be connected to an end of the chain ofsequential locking segments and an end of tube 1800, and thus, connectthe chain of sequential locking segments to tube 1800. In yet anotherembodiment, a location in the middle of tube 1800 may be connected toanother end of the chain of sequential locking segments.

FIGS. 19A-19C are graphs illustrating radii and slopes along a length ofa flexed chain of ball-shaped sequential locking segments, cone-shapedsequential locking segments, and hollow cone-shaped sequential lockingsegments, respectively. As shown in FIG. 19A, for example, the top graphillustrates a radius along the length of an inner side of a flexed chainof ball-shaped sequential locking segments. The bottom graph illustratesthat the maximum slope along the length of the flexed chain ofball-shaped locking segments is about 1.2 mm/mm. In contrast, FIG. 19Billustrates the radius (top graph) and slope (bottom graph) along alength of a flexed chain of cone-shaped sequential locking segments.Compared to the maximum slope along a length of a flexed chain ofball-shaped locking segments, the maximum slope along a length of aflexed chain of cone-shaped locking segments is reduced to about 0.4mm/mm. Accordingly, cone-shaped locking segments may provide animprovement over ball-shaped locking segments by reducing the maximumslope from about 1.2 mm/mm to about 0.4 mm/mm.

Similarly, FIG. 19C illustrates the radius (top graph) and slope (bottomgraph) along a length of a flexed chain of hollow cone-shaped sequentiallocking segments. Compared to the maximum slope along a length of aflexed chain of ball-shaped locking segments and along a length of aflexed chain of cone-shaped locking segments, the maximum slope along alength of a flexed chain of hollow cone-shaped locking segments isfurther reduced to about 0.17 mm/mm. Accordingly, hollow cone-shapedlocking segments may reduce the maximum slope to about 0.17 mm/mm, whichis lower than both ball-shaped locking segments and cone-shaped lockingsegments. The hollow cone-shaped locking segments may also differ inthat the hollow cone-shaped segments may have a comparatively reducedradius, which may reduce the force necessary to pull the chain oflocking segments into a clasp, especially in the case of increasingtension as the sling is tightened.

According to another embodiment of the present disclosure, hollowcone-shaped locking segments may comprise indentations. For example, asshown in FIGS. 20A and 20B, hollow cone-shaped locking segments 2010 maycomprise indentations 2020. Hollow cone-shaped locking segments 2010 maycomprise ball-in-socket joints, such as ball-in-socket joints 1440 ofFIG. 14 . In some embodiments, as seen in FIGS. 20A and 20B,indentations 2020 may allow adjacent locking segments 2010 to align witheach other to form a smooth surface with reduced or no ledges along aninner side of sling 2000 when sling 2000 is flexed. Accordingly, whenlocking segments 2010 are aligned with each other via indentations 2020,the radius from the centerline may be constant with zero positive slope,thereby eliminating or reducing any ledge effect with the exception ofpossible variation in force due to an angle between adjacent lockingsegments 2010.

In some embodiments, hollow cone-shaped locking segments may be strungon a band, a sling, a wire, a thread, a string, a cable, or the likewith spacers between each locking segment. For example, as shown in FIG.21 , hollow cone-shaped locking segments 2110 may be strung on a band2100 with spacers 2120 between each adjacent locking segment 2110.Similar to the hollow cone-shaped locking segments 2010 of FIGS. 20A and20B, hollow cone-shaped locking segments 2110 may comprise indentations2130. Indentations 2130 may allow adjacent locking segments 2110 toalign with each other to form a smooth surface with no ledges along aninner side of sling 2100 when sling 2100 is flexed. Accordingly, whenlocking segments 2110 are aligned with each other via indentations 2130,the radius from the centerline may be constant with zero positive slope,thereby eliminating or significantly reducing a ledge effect with theexception of possible variation in force due to an angle betweenadjacent locking segments 2110.

According to another embodiment of the present disclosure, an improvedmethod of visualizing devices is disclosed. For example, manipulationand actuation of transcatheter devices within a body is generally guidedby visualization using fluoroscopy. Accordingly, in order to aid in thevisualization of transcatheter devices using fluoroscopy, radiopaquemarkers may be used. Radiopaque markers may appear with high contrast onfluoroscopic images and may be attached to transcatheter devices atcritical locations such that the position, orientation, and/or relativepositions of the transcatheter devices can be clearly visualized.

In some embodiments, radiopaque markers may be disposed at one or morelocations on a component of a band, on the band, or on a band deliverydevice. The radiopaque markers may aid in the positioning and deploymentof, for example, a transcatheter papillary muscle band or a ventricularband. In some embodiments of the present disclosure, radiopaque markersmay aid in the positioning of a transcatheter band by providing visualconfirmation that the band is properly positioned for deployment. Forexample, for a band including a clasp, such as an actuatable clasp, at afirst end thereof that locks onto a position along the band in order toform a loop, visual confirmation that a second end of the band has beeninserted far enough into the clasp may be needed. Accordingly,accidental actuation of the clasp before sufficient insertion of thesecond end of the band into the clasp can be avoided.

In another embodiment, radiopaque markers may aid in the deployment of atranscatheter band by providing a visual confirmation that claspactuation has occurred. For example, for a band that comprises a claspthat is actuated by the retraction of a clasp retainer, visualconfirmation that the clasp retainer has actually retracted from theclasp may be needed in order to provide confidence to the user that theclasp has been actuated and is locked in place.

In yet another embodiment of the present disclosure, a band deliverydevice may comprise a radiopaque marker at a distal end thereof. Theradiopaque marker may be adjacent to a clasp disposed in the band, andthe band may comprise another radiopaque marker at a second end thereof.Accordingly, when the radiopaque marker on the second end of the bandpasses the radiopaque marker on the distal end of the band deliverydevice, this may provide confirmation that the second end of the band issufficiently inserted through the clasp that the clasp can be actuated.

In some embodiments of the present disclosure, the band delivery devicemay comprise a radiopaque marker at a distal end thereof, adjacent tothe clasp of the band, and the band insertion cable, which may beattached to the second end of the band, may comprise a radiopaque markernear a position at which the insertion cable attaches to the band.Accordingly, when the radiopaque marker on the insertion cable passesthe radiopaque marker on the distal end of the delivery device, thisprovides confirmation that the second end of the band is sufficientlyinserted through the clasp that the clasp can be actuated.

In some embodiments of the present disclosure, the delivery device maycomprise a radiopaque marker on a clasp retainer, and the band maycomprise a radiopaque marker at a second end thereof. Accordingly, whenthe radiopaque marker on the second end of the band passes theradiopaque marker on the clasp retainer, this provides confirmation thatthe second end of the band is sufficiently inserted through the claspthat the clasp can be actuated.

In some embodiments of the present disclosure, the band delivery devicemay comprise a radiopaque marker on the clasp retainer, and the bandinsertion cable, which may be attached to the second end of the band,may comprise a radiopaque marker near a position at which the insertioncable attaches to the band. Accordingly, when the radiopaque marker onthe insertion cable passes the radiopaque marker on the clasp retainer,this provides confirmation that the second end of the band issufficiently inserted through the clasp that the clasp can be actuated.

In some embodiments of the present disclosure, the band delivery devicemay comprise a radiopaque marker on the clasp retainer and a secondradiopaque marker on the distal end of the delivery device. Additionallyor alternatively, the radiopaque markers may be aligned such that, whenthe retainer is within the clasp, the radiopaque markers appear in thefluoroscopic images to be a single marker (e.g., overlapping eachother). In addition, when the retainer is retracted from the clasp, themarkers appear as two separate markers in the fluoroscopic images (e.g.,no longer overlapping each other). Additionally or alternatively, theradiopaque markers may be aligned such that, when the retainer is withinthe clasp, the radiopaque markers appear in the fluoroscopic images astwo separate markers in the fluoroscopic images, and when the retaineris retracted from the clasp the markers overlap each other and appear asa single marker in the fluoroscopic images. In some embodiments, theradiopaque markers may comprise cylindrical bands.

Referring to FIGS. 22A-22D, for example, radiopaque markers may bedisposed on a delivery device, on a clasp retainer, and on a band inorder to confirm clasp actuation. For example, as shown in FIG. 22A, aradiopaque marker 2200 a may be disposed on a distal end 2210 of adelivery device 2220, a radiopaque marker 2200 b may be disposed on aclasp retainer 2230, and a radiopaque marker 2200 c may be disposed on asecond end 2240 of a band 2250. In FIG. 22A, radiopaque markers 2200 aand 2200 b appear as a single band in the fluoroscopic image, therebysuggesting that radiopaque markers 2200 a and 2200 b are aligned andoverlapping each other. In the fluoroscopic image of FIG. 22A,radiopaque marker 2200 c on second end 2240 of band 2250 is locatedoutside of distal end 2210 of delivery device 2220, and thus, second end2240 of band 2250 has not yet passed through a clasp associated withclasp retainer 2230.

Referring now to FIG. 22B, radiopaque marker 2200 c has passed throughradiopaque marker 2200 a of delivery device 2220 and is located insidedelivery device 2220. This indicates that second end 2240 of band 2250has been inserted through the clasp and that the clasp may be actuated.Referring now to the fluoroscopic image of FIG. 22C, radiopaque markers2200 a and 2200 b appear separated and are no longer overlapping eachother. This confirms that that the clasp associated with clasp retainer2230 has been actuated, and thus, locked onto a portion of band 2250. Asseen in FIG. 22D, even when a band insertion cable 2260 is detached fromband 2250, radiopaque marker 2200 c remains on second end 2240 of band2250.

Referring now to FIGS. 23A-23D, in some embodiments, radiopaque markersmay be disposed on a delivery device, on a clasp retainer, and on a bandinsertion cable in order to confirm clasp actuation. For example, asshown in FIG. 23A, a radiopaque marker 2300 a may be disposed on adistal end 2310 of a delivery device 2320, a radiopaque marker 2300 bmay be disposed on a clasp retainer 2330, and a radiopaque marker 2300 cmay be disposed on a band insertion cable 2340. In FIG. 23A, radiopaquemarkers 2300 a and 2300 b appear as a single band in the fluoroscopicimage, thereby suggesting that radiopaque markers 2300 a and 2300 b arealigned and overlapping each other. In the fluoroscopic image of FIG.23A, radiopaque marker 2300 c on band insertion cable 2340 is locatedoutside of distal end 2310 of delivery device 2320, thereby indicatingthat an end of a band 2350 attached to band insertion cable 2340 has notyet passed through a clasp associated with clasp retainer 2330.

Referring now to FIG. 23B, radiopaque marker 2300 c has passed throughradiopaque marker 2300 a of delivery device 2320 and is located insidedelivery device 2320. This indicates that the end of band 2350 attachedto band insertion cable 2340 has been inserted through the clasp andthat the clasp may be actuated. Referring now to the fluoroscopic imageof FIG. 23C, radiopaque markers 2300 a and 2300 b appear separated andare no longer overlapping each other. This confirms that the claspassociated with clasp retainer 2330 has been actuated, and thus, lockedonto a portion of band 2350. As seen in FIG. 23D, radiopaque marker 2300c is detached from the end of band 2350, indicating that band insertioncable 2340 has been detached from the end of band 2350.

While the present disclosure is described herein with reference toillustrative embodiments of catheters, bands, and guidewires used forparticular applications, such as for papillary muscle repositioning andimproving cardiac function, it should be understood that the embodimentsdescribed herein are not limited thereto. Those having ordinary skill inthe art and access to the teachings provided herein will recognizeadditional modifications, applications, embodiments, and substitution ofequivalents that all fall within the scope of the disclosed embodiments.Accordingly, the disclosed embodiments are not to be considered aslimited by the foregoing or following descriptions.

The many features and advantages of the present disclosure are apparentfrom the detailed specification, and thus it is intended by the appendedclaims to cover all such features and advantages of the presentdisclosure that fall within the true spirit and scope of the presentdisclosure. Further, since numerous modifications and variations willreadily occur to those skilled in the art, it is not desired to limitthe present disclosure to the exact construction and operationillustrated and described and accordingly, all suitable modificationsand equivalents may be resorted to, falling within the scope of thepresent disclosure.

Moreover, those skilled in the art will appreciate that the conceptionupon which this disclosure is based may readily be used as a basis fordesigning other structures, methods, and systems for carrying out theseveral purposes of the present disclosure. Accordingly, the claims arenot to be considered as limited by the foregoing description.

1-17. (canceled)
 18. A cardiac device, comprising: a band configured fordeployment within a heart, the band including a first end and a secondend; an actuatable clasp associated with the first end of the band andconfigured to transition, upon actuation, from an open configuration toa closed configuration for forming the band into a fixed length loopafter the second end is moved beyond the clasp, and wherein the clasp isconfigured for actuation via a catheter; a clasp retainer associatedwith the clasp, the clasp retainer being configured to hold the clasp inthe open configuration and the clasp being configured to be actuatedupon movement of the clasp retainer; and a clasp actuator configured tomove the clasp retainer thereby actuating the clasp.
 19. The cardiacdevice of claim 18, wherein the actuatable clasp includes a cylinderwith a plurality of flaps protruding from one end of the cylinder. 20.The cardiac device of claim 19, wherein, in the closed configuration,the plurality of flaps are bent inward toward a center of the cylinderto form the actuatable clasp, the actuatable clasp being configured tograsp a portion of the band that passes through the actuatable clasp.21. The cardiac device of claim 19, wherein the plurality of flapsinclude pointed tips configured to engage the band when the actuatableclasp is in the closed configuration.
 22. The cardiac device of claim19, wherein the plurality of flaps include tips configured to fitbetween one or more protrusions on the band to prevent the one or moreprotrusions from passing through the actuatable clasp when theactuatable clasp is in the closed configuration.
 23. The cardiac deviceof claim 19, wherein the plurality of flaps are biased towards theclosed configuration and configured to be elastically bent into the openconfiguration to adjust the band.
 24. The cardiac device of claim 19,wherein the plurality of flaps are configured to return to the closedconfiguration upon actuation of the actuatable clasp by a claspactuator.
 25. The cardiac device of claim 18, wherein the second end ofthe band includes a plurality of protrusions, and wherein the actuatableclasp is configured to close between adjacent ones of the plurality ofprotrusions.
 26. The cardiac device of claim 25, wherein the pluralityof protrusions include at least one of beads or spikes.
 27. The cardiacdevice of claim 25, wherein the plurality of protrusions includes beadsmade of at least one of plastic or metal.
 28. The cardiac device ofclaim 25, wherein the plurality of protrusions are configured to pass ina first direction through the actuatable clasp, and wherein theactuatable clasp is configured to prevent the plurality of protrusionsfrom passing through the actuatable clasp in a second direction oppositethe first direction when the actuatable clasp is in the closedconfiguration.
 29. The cardiac device of claim 28, wherein theactuatable clasp includes a cylinder with at least one cut in a wall ofthe cylinder.
 30. The cardiac device of claim 29, further comprising aring disposed around the first end of the band over the at least onecut, the ring configured to push a material of the band into the atleast one cut.
 31. The cardiac device of claim 28, wherein the innerdiameter of the actuatable clasp is smaller than the outer diameter ofthe distal end of a delivery catheter and the outer diameter of theactuatable clasp is larger than the inner diameter of the distal end ofsaid delivery catheter.
 32. The cardiac device of claim 31, wherein thedistal end of the delivery catheter is cut with a pattern complementaryto a shape of the plurality of flaps of the actuatable clasp such thatwhen the actuatable clasp is in the open configuration, the plurality offlaps are configured to lock into the cut pattern at the distal end ofthe delivery catheter.
 33. The cardiac device of claim 32, wherein, whenthe actuatable clasp is in the closed configuration, the plurality offlaps is configured to disconnect from the cut pattern at the distal endof the delivery catheter.
 34. The cardiac device of claim 18, furthercomprising a clasp retainer ring disposed within the actuatable claspand a pull-wire coupled to the clasp retainer ring.
 35. The cardiacdevice of claim 34, wherein the clasp retainer ring is configured torelease the actuatable clasp upon actuation of the actuatable clasp bythe clasp actuator.
 36. The cardiac device of claim 34, wherein thepull-wire is connected to a trigger.
 37. The cardiac device of claim 32,wherein upon transitioning from the open configuration to the closedconfiguration, the actuatable clasp is configured to lock the band intoa loop by grasping the second end of the band and to disconnect from thecut pattern.